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Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression

NCT ID: NCT00287703

Last Updated: 2009-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-03-31

Brief Summary

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About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields) can alleviate the symptoms of depression.

Detailed Description

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In this study, a patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severity is measured at the beginning of the study and at each weekly visit. Side effects are closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).

Conditions

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Depression

Keywords

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Major depression Treatment resistant PEMF AQT Hamilton

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Active Pulsating Electro Magnetic Fields (PEMF) treatment

Group Type EXPERIMENTAL

Pulsating Electro-Magnetic Fields

Intervention Type DEVICE

5 days a week for 5 weeks 30 minutes

2

5 days a week for 5 weeks for 30 minutes Sham PEMF

Group Type SHAM_COMPARATOR

Pulsating Electro-Magnetic Fields sham

Intervention Type DEVICE

sham PEMF

Interventions

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Pulsating Electro-Magnetic Fields

5 days a week for 5 weeks 30 minutes

Intervention Type DEVICE

Pulsating Electro-Magnetic Fields sham

sham PEMF

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Major depression
* Treatment resistance
* Age above 18 years
* Hamilton 17 item score above 13
* Unaltered pharmacological treatment in last 4 weeks

Exclusion Criteria

* Psychotic disorder
* Mental retardation
* Suicidality
* Earlier treatment with PEMF
* Abuse of alcohol or other substances
* Patient not able to come to appointed visits
* Antisocial, borderline or schizotypic personality disorder
* Women lactating or pregnant
* Unreliable contraception
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Lundbeckfoundation

UNKNOWN

Sponsor Role collaborator

Biofields

UNKNOWN

Sponsor Role collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Psychiatric Research Unit, Hillerod Hospital

Principal Investigators

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Klaus Martiny, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Psychiatric Research Unit Fredericksburg General Hospital

Locations

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Speciallægerne Falkoner Allé

Municipality of Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10.

Reference Type DERIVED
PMID: 20385376 (View on PubMed)

Other Identifiers

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Final version 26 Oktober 2005

Identifier Type: -

Identifier Source: org_study_id